USPTO Patents Application 10647068

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PCT

WORLD INTELLECTUAL PROPERTY ORGANIZATION
intcmaiional Bureau

INTERNATIONAL APP LICATION PUBLISHED UNDER THE PAT ENT COOPERATION TREATY r pen

(51) International Patent Classification 5 :
A6IF

A2

(II) International Publication Number: WO 92/20299

(43) International Publication Date: 26 November 1992 (26.1 1.92)

(21) International Application Number: PCT/US92/040I9

(22) International Filing Date: | 4 May 1992 (14.05.92)

(30) Priority daU:
699,936

14 May 1991 (14.05.91) US

(60) Parent Application or Grant
(63) Related by Continuation
US

Filed on

699.936 (CIP)
14 May 1991 (14.05.91)

ri ^fl^U^85MB^ 0r: fAMIEROWSKI, David . S.
lUi/USJ, 8500 Remhart, Leawood, KS 66206 (US)7

(54) Title: FASTENING SYSTEM AND METHOD

U4)A *Sn S^vM"* E - Litma ". McMahon & Br wn
1200 Ma,n St.. Suue 1600. Kansas City. MO 64105 (US)'

(81) Designated Sates: AT (European patent) AU BR rp
(European patent). BF (OAPI patent". BG BJ fOAW
P CH?lf n K CA - CF W P a,em >« (OAM patent)
SLnrt cl^nW 0, CI (0API P* ent >. CM (O API
lenrt PC /e ° E < Euro P can P««»>, DK (European pa-
^^rffD^"™^" JK*"* FI « p R (European pa"ent)
SteS A^ 0 ' ° B (Europcan P«"ny; GN P (OAPI

ffi JP KP ( &M« 0, HU> IT ( Eu «P^n pa-
icmj, jf, rp, kj^ LK, LU (European patent) MC fEu

fPHH^&'S' ( ° API ^ MN MrYoa-
RUS^W NL ( Eur °P ean Patent). NO, PL, RO.
SH'™' SE (Ewopean patent), SN (OAPI patent) TD
(OAPI-patent), TG (OAPI patent). US. P } "

Published 'fit.

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VACUUM

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(57) Abstract

and distal ends and a sheath p^e xfend £Z S^^^SSS 9 V"** -■fit-™*-* with proximaTe
adhesively securing the sheath assembly idjivSiuISiS ^ CM ^ f8S,Cned ,0 ,he m ""brane assembly by

seam. A sheath-to-tube fastener is vnJdi^^!^S^!S^J^ t TiT* PandS 31 ,he membrane

FOK THE FUKFOSES OF INFORMATION ONLY

AT

AMiria

AU

Autfralia

US

Bartoado*

•E

Belgium

tF

Bvrima Kujo

•G

Bulgaria

•J

Benin

till

Brv.il

CA

Canada

CF

Central African Republic

cc

Congo

CM

SwiUctland

a

Co<c d*Uuire

CM

Camcruuu

cs

(I/cchudovaiia

f icrmaiiy

IMC

Denmurfc

es

Spain

n

Knland

PR

France

CA

(iahou

C8

United Kingdom

CN

Guinea

CK

CJrcccc

NU

Hungary

IE

Ireland

rr

Italy

jf

Japan

KF

IXriTHjcfatk Pv«t»k.» Republic

«*f Korea

Kit

Republic of Korea

LI

tnxhtcrtoicin

LK

Sri l^utka

LU

l-ukerrUtourg

MC

Mortjto

MC

M,«dagaM.ar

Ml.

Mali

MN

Mongolia

MR

Mauritania

MW

Malawi

NL

Net her tana*

NO

PL

Poland

RO

Romania

RU

Ruauan Federation

SO

Wan

se

Sweden

SN

Senegal

SU

Soviet Union

TO

Chad

TC

Togo

US

United Skate* of America

WO 92/20299

PCT/US92/04019

1

FASTENING SYSTEM AND METHOD

Background of the Invention
!• Field of the Invention
5 The present invention relates generally to fastening

systems, and in particular to a system and method for
fastening tubes to patients.

Descript ion of the Related Aft
10 Various fastening systems and" methods have heretofore

been devised for meeting the requirements of particular
applications. For example, in the medical field, a variety
of fastening systems are employed in connection with various
medical procedures. Previous medical fastening systems
15 include sutures, clamps, belts, ties, adhesive tape and other
tapes. Common medical fastening procedures include fastening
tubes to patients.

Medical patients are intubated in connection with a
number of common medical procedures. For example, nasogastric
20 tubes are inserted into the patient's stomach via a nostril
for aspirating the stomach contents. Tubes are commonly
inserted through stomal openings, e.g., in connection with
ileostomies, gastrostomies, etc.

Intravenous (IV) tubing, catheters, fiber optic cables
25 and electrical wire leads from electrodes all present problems
associated with fastening tubes, cables and leads to patients.
Frequently, a tube-to-patient connection with some structural
integrity is desired, i.e., to reduce the risk of injury from
the tube being torn loose from the patient. Since
30 considerable tensile force can be exerted on such tubing

WO 92/20299

PCT/US92/04019

2

10

(e.g., by an intubated patient rolling over in bed), previous
solutions such as secure taping with strong adhesive tape have
been utilized with some success. However, there are
disadvantages associated with the prolonged application of
adhesive tape. since many types of adhesive tape used for
medical applications, are relatively impervious, skin covered
thereby is susceptible to maceration and the formation of
milia consisting of inflamed hair follicles and glands.

Tubes and other flexible lines can also be sutured to
patients, but there are disadvantages associated with this
technique. For example, the sutures can be uncomfortable to
the patient, and can cause infection, inflammation and
scaring.

Improved patient comfort can be achieved by applying
15 semi-permeable membranes, which tend to be permeable to
vapors, to wound sites. Such membranes are available from
several companies, including: "Polyskin" from Kendall Health
Care Products Company; "Opsite" from Smith 6 Nephew, inc. ;
"Bioclusive" from Johnson S Johnson Products, inc.; and
20 "Tegadern" from 3M Health Care. Such membranes commonly have
adhesive faces for adhesion to patient's skin, but are
normally relatively thin with little structural integrity.
Thus, for all of their patient comfort advantages, the semi-
permeable membranes are often not a satisfactory substitute
25 for adhesive tape.

Tapes are also available which have permeable
characteristics, but many of them lack sufficient structural
integrity for practical use as the sole and exclusive
fastening system for tubes and other flexible lines.

3

However, the semi-permeable membrane materials referred
to above can be combined with other, stronger materials, such
as flexible plastic tubing, to provide wound dressings with
considerable advantages over previous, conventional gauze-and-
5 tape dressings. The Zamierowski U.S. Patent No. 4,969,880
discloses such a wound dressing which effectively exploits the
combined advantages, of semi-permeable- membranes and flexible
plastic tubing..

The applicability of such a combination to a. variety of
10 fastening applications is addressed by the present invention.

Another problem commonly encountered in medical surgical
procedures relates to the evacuation of blood from the
operating site. Devices have been. provided for capturing the
blood and other fluids, e.g., eye drains available frn
15 Merocel Corporation which are fastened to patient's cheeks
during ophthalmologic procedures. Sponges and gauze are often
used for evacuating blood and other fluids from operating
sites. Suction tubes are also utilized, e.g., with cannulae,
and can be provided with small sponge attachments on their
ends for gathering fluid, e.g. Tebbett's suction pads
available from Dow Corning. The present invention can be
utilized as a device for fastening and fluidically
communicating surgical sponges with suction for the collection
of blood and other fluids during surgery, which can reduce the
need for handling and weighing blood-saturated sponges in the
operating room, which is frequently required at present to
determine a volume of blood replacement required for a patient
during surgery.

20

25

30

Summary of the Invention

WO 92/20299 PCT7US92/04019

4

In the practice of the present invention, a fastening
system and method are provided for fastening a variety of
tubes to patients for performing various medical procedures
thereon. The fastening system can- comprise a membrane
5 assembly consisting of a pair of membrane body panels
adhesively joined at a seam extending transversely across the
membrane assembly. The membrane assembly can comprise a semi-
permeable material with an adhesive* "face covered by an
adhesive backing prior to use. A sheath assembly includes
10 proximate and distal ends and a sheath passage extending
therebetween. The sheath assembly is fastened to the membrane
assembly by extending the sheath assembly between the body
panels at the membrane assembly seam in proximity to the
sheath assembly proximate end, which can be split to form a
15 pair of sheath proximate end tabs. A sheath-to-tube fastener
is provided for fastening the sheath to a tube inserted in the
patient. The fastening system can also mount the sheath
adjacent to an end edge thereof, for example in a fastening
system construction particularly designed for fastening a
20 nasogastric tube to a patient. A surgical suction fastening
system is also disclosed wherein a sponge is sandwiched
between the panels of the membrane assembly with a portion of
the sponge extending beyond a membrane assembly for drawing
fluids, e.g., blood from a surgical site. Methods of
25 fastening the present invention in connection with various
medical procedures are further disclosed, particularly those
involving intubation of a patient, e.g., nas gastric, suction,
intravenous, Foley catheter, stomal and percutaneous tubing.
Another method in the practice of the present invention
30 involves sandwiching a surgical sponge between the membrane

5

assembly panels and fastening the sheath to a suction tube for
suction evacuating blood from an operating site.

Obi acts and A dvantages of the Invent^ op
5 The principle objects and advantages of the present

invention include: providing a fastening system and method,
providing such a fastening system and method which are
particularly well-adapted for medical applications; providing
such a system and method for fastening tubing to a medical
10 patient; providing such a system and method for fastening a
surgical sponge to a suction source in fluidic communication;
providing such a system and method which have considerable
structural strength; providing such a system and method which
are relatively comfortable to patients; providing such a
15 system and method which can reduce or minimize maceration and
the formation of milia as compared to adhesive tape systems
and methods; providing such a system and method which allow
a wide variety of applications with a common device; providing
such a device and method which can help control nosocomial and
20 other infections; and providing such a device and method which
are efficient in operation, economical to manufacture and
practice, and are particularly well designed for the proposed
usages thereof.

Other objects and advantages of this invention will
25 become apparent from the following description taken in
conjunction with the accompanying drawings wherein are set
forth, by way of illustration and example, certain embodiments
of this invention.

WO 92/20299 PCT/US92/04019

6

The drawings constitute a part of this specification and
include exemplary embodiments f the present invention and
illustrate various objects and features thereof.

5 Brief Description of the Drawings

Fig* 1 is a perspective view of a fastening system
embodying the present invention , shown fastening a nasogastric
tube- . m .

Fig. 2 is an enlarged, perspective view of the fastening
10 system, shown prior to application to a patient*

Fig* 2a is a plan view of a. fastening system for a
nasogastric tube comprising a first modified or alternative
embodiment of the present invention*

Fig. 3 is an enlarged, fragmentary, cross-sectional view
15 of the fastening system, taken generally line 3-3 in Fig. 2.

Fig. 3a is an enlarged, fragmentary, cross-sectional view
thereof taken generally along 3a-3a in Fig. 2a.

Fig. 4 is a side elevational view of the fastening
system.

20 Fig. 5 is an enlarged cross-sectional view of the

fastening system taken generally along line 5-5 in Fig. 4.

Fig. 6 is a side elevational view of the fastening
system, showing the nasogastric tube partially within a sheath
thereof .

25 Fig. 7 is an enlarged cross-sectional view of the

fastening system, taken generally along line 7-7 in Fig. 6.

Fig. 8 is a side elevational view of the fastening
system, particularly showing the nasogastric tube enclosed
within the sheath and secured by a cinch loop fastener.

W0 92/20299 PCT/US92/040I9

7

Fig. 9 is an enlarged cross-sectional view of the
fastening system taken generally along line 9-9 in Fig. 8.

Fig. 10 is a perspective view or a fastening system for
a surgical sponge comprising a second modified or alternative
5 embodiment of the present invention.

Fig. li is an enlarged, fragmentary, cross-sectional view
thereof, taken generally along line li-n in Fig. io.

Fig. 12 is an. enlarged cross-sectional view thereof taken
generally along line 12-12 in Fig. 10.
10 Fig. 13 is a cross-sectional view of a fastening system

comprising a third modified or alternative embodiment of the
present invention, shown fastening an intravenous tube to a
patient.

Fig. 14 is a plan view of a fastening system comprising
15 a forth modified or alternative embodiment of the present
invention, shown attaching a Foley catheter to a patient.

Fig. 15 is an enlarged, fragmentary, cross-sectional view
thereof taken generally along line 15-15 in Fig. 14.

Fig. 16 is a perspective view of a fastening system
20 comprising a fifth modified or alterative embodiment of the
present invention, showing a pair of tubes attached to the
fastening system for connection to a patient.

Fig. 17 is a fragmentary, perspective view of a fastening
system comprising a sixth modified or alternative embodiment
25 of the present invention, with a hook-and-loop fastener for
fastening a sheath.

Fig. 18 is a fragmentary, side elevational view of a
wound dressing system comprising a seventh modified or
alternative embodiment of the present invention.

WO 92/20299 PCT/US92/04019

8

Fig. 18a is fragmentary, side elevational view thereof,
particularly showing a suction tube proximate end prior to
insertion into a sheath.

Fig. 18b is a fragmentary, side elevational view thereof,
5s particularly showing the suction tube proximate end inserted
into the sheath.

Fig. 19- is- a top perspective view of a suction sponge
system comprising an eighth modif ied or alternative embodiment
of the present invention.
10 Fig. 20 is a perspective view of an extremity fluidic

connection system comprising a ninth modified or alternative
embodiment of the present invention.

Fig. 21 is an enlarged, fragmentary, cross-sectional view
thereof, taken generally along line 21-21 in Fig. 20.
15 Fi S« 22 is an enlarged, fragmentary, cross-sectional view

thereof, taken generally along line 22-22 in Fig. 20.

Fig. 23 is an enlarged, fragmentary, cross-sectional view
thereof, taken generally along line 23-23 in Fig. 20.

Fig. 24 is a perspective view of an intravenous tube
20 system including a cinch loop fastener comprising a tenth
modified or alternative embodiment of the present invention.

Fig. 25 is a top plan view of the cinch loop fastener in
an open position thereof.

Fig. 26 is a bottom plan view of the cinch loop fastener.
25 Fig. 27 is a perspective view of the cinch loop fastener

showing a preliminary stage of fastening to an IV tube.

Fig. 28 is a perspective view of the cinch loop fastener,
showing an intermediate stage of fastening to the IV tube.

Fig. 29 is a side elevational view of the cinch loop
30 fastener, shown fastened to the IV tube.

Fig. 30 is a perspective view of the cinch loop fastener,
shown fastened to the IV tube.

Detailed Descript ion of the Prefer ™* P"H ndiments
!• Introduction and Environment?

As required, detailed embodiments of the present
invention are disclosed herein; however, it is to be
understood that the disclosed embodiments are merely exemplary
of the invention, which may be embodied in various forms.
Therefore, specific structural and functional details
disclosed herein are not to be interpreted as limiting, but
merely as a basis for the claims and as a representative basis
for teaching one skilled in the art to variously employ the
present invention in virtually any appropriately detailed
structure.

Certain terminology will be used in the following
description for convenience in reference only and will not be
limiting. For example, the words "upwardly", "downwardly" ,
"rightwardly" and "leftwardly" will refer to directions in the
drawings to which reference is made. The words "inwardly" and
"outwardly" will refer to directions toward and away from,
respectively, the geometric center of the embodiment being
described and designated parts thereof. Said terminology will
include the words specifically mentioned, derivatives thereof
and words of a similar import.

II. nasogastric Tube Fastening System 2

Referring to the drawing in more detail, the reference
numeral 2 generally designates a medical fastening system
which embodies the present invention. Without limitations on

WO 92/20299 PCI7US92/04019

10

the generality of useful applications of the medical fastening
system 2, it is shown applied to a medical patient 1 s face 4
attaching a nasogastric tube 6, which is inserted through a
nostril 8 of the patient for aspirating the stomach contents.
5 The fastening system 2 generally comprises a membrane

assembly 10 , a sheath assembly 12, and a sheath-to-tube-
fastener 14 .

The membrane assembly 10 includes a first body panel 16~
with first and second end edges 18, 19 and opposite side edges

10 20. A membrane flap or extension 22 extends from the first
end edge 18 and includes a first flap panel 24, which can be
integral with the body panel 16, and a second flap or body
panel 26. The body panel 16 includes an adhesive layer 2ff
which can be covered by an adhesive backing 30.

15 The body panel 16 and the flap panels 24, 26 can comprise

a vapor-permeable, transparent, polyurethane film material of
the type which is available from a number of manufacturers,
e.g.: "Tegaderm" dressing from the 3M Company; "Bioclusive"
dressing from Johnson Johnson Products, Inc.; "OpSite*

20 dressing from Smith & Nephew Inc.; and "Polyskin" dressing
from Kendall Health Care Products, Inc.

The flap or extension 22 includes a proximate edge 32
connected to the body first end edge, a distal edge 34,
opposite side edges 36 and an adhesive seam 27 between

25 adhesive layers 23, 25 on the first and second flap panels 24,
26.

The sheath assembly 12 includes proximate and distal ends
38 , 40 with first and second sheath faces 41, 42 each having
an adhesive layer 4 4 thereon adjacent to a sheath passage 46.
30 An adhesive release strip 4 8 extends through the sheath

10

20

25

30

W0 92/20299 PCT/US92/040I9

11

passage 46. One or both of the sheath faces 41, 4 2 can be
provided with a tear line or marking 50 for access to the
passage 46.

A method of fastening the nasogastric tube 6 to a patient
5 is disclosed, and includes the steps of pealing away the
adhesive backing 30 and adhesively securing the body panel 16
to the nose and/ or cheeks of the patient's face 4 (Figs, l and

The flap or extension 22 comprises a double layer of the
semi-permeable membrane material with adhesive layers 28
thereof attached at the seam 27 whereby the flap or extension
22 will not adhere to the patient. The sheath assembly 12 can
overlie the tube 6, as shown in Figs, l, 4 and 5, and can be
temporarily secured thereto with a cinch loop fastener 52 as
shown in Fig. 6. The cinch loop fastener 52 can include a
hook-and-loop fastener 54 for releasably cinching the sheath
assembly 12 to the tube 6. Such a fastener is shown in Fig.
9. However, various other sheath-to-tube fastening means
could be employed, including twist ties, rubber bands, clips,
etc. By employing a releasable fastener 52, the tube 6 can
easily be repositioned with respect to the fastening system
2. The position of the tube 6 can be confirmed by x-ray
examination or by other means, and can be adjusted if
necessary.

When the tube 6 is properly positioned, it can be
resecured. to the fastening system 2 by opening the sheath
assembly 12 and placing the tube 6 within the sheath passage
46. The sheath assembly 12 can be opened by cutting it
longitudinally, or by tearing it along a tear line 50 to
provide access to the passage 46. The adhesive release strip

15

WO 92/20299 PCT/US92/04019

12

48 can then be removed from the sheath assembly 12 and the
tube 6 placed in the passage 46 as shown in Fig. 8. The
sheath 12 can then be folded over the tube 6 (Figs. 7 and 9),
The tube 6 can be adhesively secured in place by pressing the
5 adhesive layers 44 of the sheath 12 thereagainst. The tube
6 can also be secured within the sheath 12 by the cinch loop
fastener 52. (Fig. 9) With the tube 6 thus secured, the tube
is relatively securely attached to the patient.. Patient
comfort is facilitated by the use of the semi-permeable
10 material for the membrane assembly 10 , which passes vapors and
air for breathability. Thus, as compared to relatively
impervious fastening systems (e.g., adhesive tape), greater
patient comfort can be achieved and skin problems such as
maceration or formulation of milia (gland or hair follicle
15 inflammation accompanied by pustules) can be reduced.
Furthermore, the nasal tip and the nostril rim area of the
patient can be observed for evidence of inflammation,
infection, etc., and can be promptly detected. Furthermore,
necrosis of the nostril tip, which often accompanies overly
20 forceful adhesive taping, can be observed and therefore
minimized or avoided.

A fastening system 2a comprising a first modified or
alternative embodiment of the present invention is shown in
Figs. 2a and 3a. The fastening system 2a is particularly
25 adapted for fastening a nasogastric tube 6, but like the
fastening system 2, could also fasten an intravenous tube and
other types of tubing and flexible lines. The fastening
system 2a includes an intermediate membrane strip 4a
adhesively attached to a first flap panel 24a. The first flap
30 panel 24a includes an end portion 26a with adhesive backing

13

layer 28a which can be peeled away for exposing an adhesive
layer 3 0a.

In using the fastening system 2a, a body adhesive backing
32a is peeled away from the. membrane 4a to expose the adhesive
layer 30a , and the membrane 4a is applied to the patient as
described above. The first flap panel 24a is preferably
positioned, in proximity to the patient's nostrils , and since
it does not have any exposed adhesive, the fastening system
2a can be utilized to leave the patient's nostrils clear for
breathing. The extension adhesive backing 28a is peeled away
to expose the adhesive layer 30a and the membrane end portion
26a can be wrapped around the nasogastric tube 6 for securing
same to patient.

III. Suction Fastening System 102

A surgical suction fastening system 102 comprises a
second modified or alternative embodiment of the present
invention and is shown in Fig. 9. The surgical suction
fastening system 102 generally includes a membrane 104, a
sheath assembly 106 and a sponge assembly 108. The membrane
and sheath assemblies 104, 106 can comprise, for example, a
wound dressing as shown in my U.S. Patent Application Serial
No. 504,598 for fluidic connection system and method, which
is co-pending herewith and which is incorporated herein by
reference, along with my U.S. Patent No. 4,969,880.

The membrane assembly 104 comprises a pair of semi-
permeable panels 110 which are adhesively joined at a membrane
assembly seam 112 whereat a proximate end 114 of the sheath
assembly 106 is secured in position. The sheath proximate end
114 forms a split mouth 116 with first and second mouth tabs

WO 92/20299 PCT/US92/04019

I

118, 120 each positioned adjacent to a respective membrane j
assembly panel 110.

The sponge 108 includes a first or open face 122 and a
second or occluded face 124, proximate and distal ends 12 6 ,
5 128 and opposite side edges 130. A sponge backing material
or layer 132 which can cover the second or occluded face 124
of the sponge 108 and can be relatively impervious. As showir
in Fig. 11, the sheath split mouth lie is adapted: to receive:
a portion of the sponge 108 between the mouth tabs 118, 120
10 adjacent to the sponge proximate end 126.

In operation, the fastening system 102 can be used singly
or in multiples to draw blood from an open dissection plane,
particularly for the purpose of maintaining a- critical point
free of blood. The sheath assembly 106 can be attached, e.g.,
15 by twist ties 134, to a suction line 136 in an area between
a distal end 138 of the sheath assembly 106 and the membrane
assembly seam 112. The suction tube 136 can be attached to
a suitable suction source (not shown) . The membrane assembly
104 can comprise either impervious (e.g., thin, flexible) or
20 semi-permeable material. Exposure to and immersion in bl od
and other fluids may cause a semi-permeable material to become
less permeable, with a corresponding enhancement of the
suction capabilities of the system 102.

The membrane, sheath and sponge assemblies 104, 106, 108
25 can be manufactured or preassembled in various configurations.
Alternatively, the fastening system- 102 can be assembled by
the health care practitioner by placing a suitable sponge
assembly 108 in a premanuf actured membrane assembly 104 and
sheath assembly 106 , which could be similar to my fluidic
30 connection system disclosed in my U.S. Patent Application

15

Serial No. 504,598 referred to above. Preferably the material
comprising the sponge 108 is resistant to shredding and strong
enough to not break apart or disintegrate in the wound or
operating site. The sponge 108 could be threaded with a
radio-opaque thread (e.g., where the membrane assembly panels
110 are joined to the sponge 108 in a middle area thereof) to
provide greater structural integrity and also to facilitate
detection by X-ray if the sponge were lost in the wound. By
providing transparent, or at least translucent, membrane
assembly panels 110 and a sheath assembly 106, the movement
of blood through the system 102 can be observed. Furthermore,
an anti-clotting coating can be provided on the sponge 108 to
facilitate efficiency. It is anticipated that most of the
blood and fluid would enter the sponge 108 through the exposed
area of the first or open face 122 of the sponge 108 through •
the exposed portions of the sponge side edges 130, and through
the sponge distal end 128. However, the sponge 108 could be
provided without a backing material or layer 132 for suction
through its second face 124.

The sheath, assembly 106 preferably is relatively flexible
for mobility of the fastening system 102 . The sheath- assembly
106 can be prevented from collapsing under the suction force
by providing it with permanent, crimped edges. Foldable, flat
sheathing is available from Aero International, Inc. of
Reading, Pennsylvania. Alternatively, the sheath assembly 106
can have longitudinal ridges for providing resistance to
collapse. The sheath, assembly 106 can have a length of about
eighteen inches to twenty-six inches for many uses, but its
length is practically unlimited. Various connector devices
can be used for attachment to the sheath assembly 106, such

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10

15

16

as a male adapter, which is sometime referred to as a
"Christmas tree" for insertions in standard suction tubing,
or a. "suction block" for allowing multiple fastening systems
102 to be connected to a common suction source. Rubber bands
O-rings, tape and other fastening systems can be used for the
sheath-to-tube fastening means. Suction devices such as th se
commonly used in tonsillectomies can be employed. The blood
and fluid connected through the fastening, system- 102 can be
collected remote from the patient for measurement to determine
how much, if any, fluid is to be replaced in the patient.

Intravenous Tube f astening system 202

An intravenous ("IV") tube fastening system 202
comprising a third modified or alternative embodiment of the
present invention is shown in Fig. 13. A membrane assembly
204 and a sheath assembly 206 can be substantially the same
as the membrane and sheath assemblies 104, 106 described above
in connection with the surgical suction fastening system 102.
The IV tube fastening system 202 can be applied over an
20 iv site or a cannula 208 inserted into the vein of the patient
through a skin puncture site 210. The cannula 108 can be
fitted at its distal end with a heparin lock 12 which can lie
adjacent to the skin surface.

By forming the membrane assembly 204 of a transparent or
25 translucent material, the heparin lock 212 can be observed
through the membrane assembly 204 which overlies it. A
hypodermic needle 214 can be inserted through the membran
assembly 204 and into the heparin lock for fluidically
connecting an IV tube 216 connected to the needle 214 with the
cannula 208 whereby an intravenous flow of fluid can be

30

17

10

15

20

established. The IV tube 216 can be secured to the sheath
assembly 206 by any suitable means including those discussed
above. By effectively utilizing the strength, adhesive and
vapor permeability properties of the membrane assembly 204 and
the sheath assembly 206, the IV puncture site 210 can be
effectively closed off against bacteria to reduce the risk of
infection, and the IV tube 216 can be effectively secured to
the patient to minimize the risk of being inadvertently pulled
loose. The semi-permeable nature of. the membrane assembly 204
can facilitate patient comfort, particularly if the IV system
is left in place for a prolonged period of time. The
transparent or translucent nature of the membrane assembly 204
facilitates observation of the puncture site 210, whereby
inflation or infection can be promptly detected and treated.

v » Polev Catheter F astening system any

A Foley catheter fastening system 302 comprising a fourth
modified or alternative embodiment of the present invention
is shown in Figs. 14 and 15, and generally comprises a
membrane assembly 304 and a sheath assembly 306, which can be
generally similar to the membrane and sheath assemblies
described above in connection with the fastening systems 102
and 202.

In the application of the fastening system 302 to a
25 patient, a Foley catheter 308 is applied to the patient by
inserting a catheter tube 310 thereof through the urethra and
into the bladder of the patient. The tube 310 mounts a
balloon on the end thereof which can be inflated with air or
liquid in the patient's bladder. The fastening system can be
0 applied by slipping the sheath 306 over the catheter tube 310

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FC1/US92/04019

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and adhesively securing panels 312 of the membrane assembly
304 to the patient's penis 314. Sheath end tabs 316 can be
placed on top of and below the glans or penile head 318.

The sheath 306 can be secured to the tube 310 by suitable
5 sheath-to-tube fasteners 3^0, which can be of any of the types
discussed above. The membrane assembly 304 in conjunction
with the sheath. assembly 306, would enclose the.
meatal/catheter junction 322 and could be helpful in*
controlling nosocomial infection entering the urethra through.
10 this junction.

Due to the transparent or translucent nature of the
membrane assembly 304, the catheter tube 310 can alternatively
be inserted after the fastening system 302 is in place by
sliding it through the sheath assembly 306 and then into the
15 urethra.

71 • multiple Tube Fastening fivafcgm aci?

A multiple tube fastening system 402 comprising a fifth
modified or alternative embodiment of the present invention
is shown Fig. 16 and generally comprises a membrane assembly
404 and a sheath assembly 406, which can be substantially
similar to the membrane and sheath assemblies described above
in connection with fastening systems 102, 202 and 302. A
percutaneous tube 408 and a suction tube 410 extend into the
25 sheath assembly 406 in juxtaposed relation. The sheath
assembly 406 can be longitudinally, axially split from a
distal end 412 of the sheath assembly 406 to a location in
spaced relation from the membrane assembly 404, whereby first
and second sheath half-sections 414, 416 are formed. The
first sheath half-section 414 can be attached to the

20

30

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percutaneous tube 4 08 by suitable fastening means 418, and the
second sheath half-section 416 can be fastened to the suction
tube 410 by similar fastening means 318.

The fastening system 402 can be used in conjunction with
5 a gastrostomy or antrostomy tube 408, with the suction tube
. . 410 provided for draining fluid leakage from around the stomal
..site. The suction tube 410 can terminate at a proximate end
air 420 in proximity to a proximate end 422 of the sheath assembly
• 406. A relatively fluid-tight connection can be formed
10 between the sheath assembly 406 and 'the tubes 408, 410 with
a sheath- to- tube fastening means 424, or adhesive on the
inside of the sheath assembly 406, or a combination of both.
In this manner irrigation and suction can be applied
simultaneously or consecutively without having to remove or
15 disturb the fastening system 402.

Without limitation on the generality of useful
applications of the fastening system 402, it is applicable to
other surgical procedures such, as ileostomy and the placement
of ileo conduits, and virtually any other stomal procedures.
20 Alternatively, the fastening system 402 can include a

sheath assembly in the form of a Y-connector or T-connector
with supply sources of liquid connected to one branch of the
connector and suction sources connected to the branch. Still
further, multiple sheath assemblies 406 can be connected to
25 the membrane assembly 404. Tubing and other flexible lines
for multiple functions can also be achieved with the fastening
system 402 by providing tubing with multiple lumens. Such
flexible lines can comprise tubing, electrical wires, e.g.,
connected to electrodes, fiber optic cables, etc.

30

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711 • fastening System 502 with i ntegral Sheath Atta^h™^

A fastening system 502 with an integral sheath clamp 504
is shown in Fig. 17 and comprises a sixth modified or
alternative embodiment of the present invention. The
5 fastening system 502 includes a sheath assembly 506 which can
otherwise be substantially similar to the sheath assemblies
106, 206, 306 and 406 described above. The integral sheath
clamp 504 comprises first and second fastening patches 508,
510 secured to the sheath assembly 506 in proximity to
10 respective opposite second side edges 512, 514 of the sheath
assembly 506. The fastening patches 508, 510 can comprise,
for example, the hook and loop components of a hook-and-loop
fastening system, such as that available under the trademark
"VELCR0-. Alternatively, the fastening system 502 can
15 comprise other types of mechanical fasteners, such as snaps,
etc., or adhesive fasteners. The sheath clamp 504 is
particularly useful for temporarily securing a tube to the
sheath assembly 506, or as in the step shown in Fig. 6 for
temporarily securing a nasogastric tube 6. By including the
20 sheath clamp 504 in the sheath assembly 506, convenience in
use can be facilitated because the health care provider does
not need to locate a clamping device, which might otherwise
be subject to becoming lost or misplaced.

25 VIII. Wound Dressing System 60J

A wound dressing system comprising a seventh modified or
alternative embodiment of the present invention is shown in
Fig. is and is generally designated by the reference numeral
601. The wound dressing system 601 can be applied to a wound

30 site 602 which is surrounded by healthy skin 604. The

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21

dressing system 601 generally consists of panel means 606,
fluid control means 608 and conduit means 610.

The panel means 606 can comprise a pair of panel sections
612. joined at a seam 614. The panel sections 612 can comprise
5 a variety of different materials, including semi-permeable
membranes such as "Tagaderm", which is available from the 3M
(Minnesota Mining and Manufacturing) Company of St. Paul,
Minnesota.;. The panel sections 612 can also comprise, for
example, occlusive, impermeable and impervious films, sheets
10 and layers of various materials which can be chosen for
desired characteristics in connection with dressing a
particular wound. Such characteristics and criteria might
include, for example, permeability, porosity, thickness,
flexibility, fluid absorption, hypoallergism, the presence or
15 absence of adhesive coatings, etc. The panel sections 612
have inner and outer surfaces 616, 618. The panel section
inner surfaces 616 can be coated with adhesive 619 to provide
fixation means for affixing the panel means 606 to the
adjacent healthy skin 604 around the perimeter of the wound
20 602. Adhesive tape 620 can be used as an alternative or
supplementary fixation means.

The fluid control means 608 can comprise a variety of
materials which can be disposed intermediately between the
wound 602 and the panel section inner surfaces 616. Such
25 materials for the fluid control means 608 can include gels
such as "Vigilon" primary wound dressing, which is available
from C. R. Bard, Inc., Bard Home Health Division, Berkeley
Heights, New Jersey, and membranes such as "Mitraflex" wound
dressing, which is available from Calgon Corporation,
30 Subsidiary of Merck & Co., Inc., St. Louis, Missouri. The

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fluid control means can be adapted to meet the requirements
of particular wounds 602 being treated. For example,
materials can be chosen for their characteristics of
permeability or impermeability, absorptive properties and
5 anti-coagulation properties. Hydrophilic and hydrophobic
properties can also be important for the fluid control mean*
608. Various types of mat materials and sponge or foam-
materials with f luid-wicking properties can be utilized for
the fluid control means 608. The properties of the fluid
10 control means. 608 preferably compliment the properties of the
panel means 606. to provide the desired fluid control for the
wound dressing system 601.

The conduit means 310 includes a sheath 322 which can
comprise, for example, a sheath such as that which is
available from Aero International, inc., of Reading,
Pennsylvania. The sheath has a proximate end 624 which is
captured within the panel seam 614 and is open at the panel
section inner surfaces 616, a distal end 626 located in spaced
relation outwardly from the panel section outer surfaces 618,
20 and a sheath passage 628 extending between the sheath ends
624, 626. The sheath distal end 626- has a tapered
configuration which converges to a neck opening 627 having a
reduced diameter as compared with the rest of the sheath
passage 628.

25 The panel means 606 and the sheath 622 described thus far

can be generally similar to any one of several combined panel
(or membrane) and sheath systems described in my U.S. Patents
No. 4,969,880 and No. 5,100,396, which are incorporated herein
by reference.

15

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23

The conduit means 610 also includes a suction tube 630
with proximate and distal ends 332, 334 and a tube passage 336
extending therebetween. The tube proximate end 332 can be
located between the wound 602 and the fluid control means 608,
5 particularly in a system 601 with impervious, hydrophobic
fluid control means 608. In such a system the fluid control
means 608 would form a fluid barrier, trapping fluid between
the wound 602 and the. fluid control means 608 for evacuation
by the suction tube 630 through its proximate end 632. The
10 tube distal end 634 is connected to" a suitable suction or
vacuum source 63 2.

The sheath 622 is provided with means for engaging th
suction tube 630 in a fluid-tight gripping engagement. Such
means can comprise, for example, one or more encircling ties
15 640 which can be formed with suture threads, rubber bands,
cinch loop fasteners 52 as described herein, etc. Such
gripping engagement means can also comprise, for example, the
configuration of the sheath distal end 626 with a relatively
narrow neck opening 627 and a slightly tapered configuration
20 converging towards the sheath distal end neck opening 627 as
described above. This configuration of the sheath distal end
626 permits a tube-securing procedure wherein the tube
proximate end 632 is inserted through the sheath distal neck
end opening 627 (Fig. 18a) , thus pushing an outer portion of
25 the sheath 622 into the sheath passage 628 whereby the sheath
622 is doubled on itself. The resulting structure (Fig. 18b)
can then be secured with ligatures 640 or other suitable,
encircling fastening means or clamps to provide an extra
measure of security against leakage, thereby enhancing the
30 effectiveness of the vacuum source 638 and minimizing the risk

W0 92/20299 PCT/US92/04019

24

of bacteria entering the wound site 602 along the suction tube

630.

The system. 601 is adapted for the- introduction of fluids
as well as the evacuation thereof. Thus, various fluids such
5 as antibiotics, growth factor, liquid medications, enzymes',"
etc. can .be introduced to the wound site 602. Liquids can
also be introduced to the wound site 602 for the purpose of
irrigating the wound.. Such liquids can be removed by using
the wound dressing system 601 in a suction/drainage mode of
10 operation. Multiple wound dressing systems 601 can be
employed for simultaneous introduction, and evacuation of
fluids. The wound dressing system 601 can be used in tandem,
or with multiple conduit means 610 for simultaneous fluid
introduction and evacuation. The wound dressing system 601
15 is adapted for dressing a variety of wounds, particularly
cavitary wounds, such as might result from a skin graft
procedure at a donor location, a bum, a decubitus, ulcer, etc.
The wound dressing system 601 can be preassembled and
prepackaged in various size and component material
20 combinations, with, the appropriate prepackage system being
selected by the health care practitioner based upon the
requirements for dressing a particular wound. Alternatively,
the components can be assembled in situ, for example, in an
operating room or in a health, care facility, by the health
25 care practitioner. The size relationships of the various
components can vary according to the conditions of particular
wounds being dressed. For example, the fluid control means
608 can be relatively large and the panel means 606 can be
relatively small for placement at any one of a variety of
30 locations on the fluid control means 608. Possible

WO92/20299 PCT/US92/04019

25

configurations include placement of a relatively small panel
means 606 at an edge of the fluid control means 608, placement
of a relatively small panel 606 at or near the center of a
relatively large fluid control means 608 with the suction tube
5 630 extending through an opening in the fluid control means
608, etc.

IX. Suction ggonge System 70 l

A suction sponge system 701 comprising an eighth modified
10 or alternative embodiment of the present invention is shown
in Fig. 19. The suction sponge system 701 generally comprises
panel means 702, sponge means 704 and conduit means 706. The
sponge means 704 can assume various configurations to
accommodate the requirements of particular applications. The
15 sponge means 704 as shown in Fig. 19 is generally rectangular
in form, with inner and outer sponge faces 708, 710, and a
perimeter edge 712.

Without limitation on the generality of useful sponge
materials, exemplary sponge materials include "Merocel", and
20 materials available from ASSI, Wick, Dow-Corning-Wright, Axiom
Medical Products, Inc. and' Davol, Inc. subsidiary of c. R.
Bard, Inc. Such materials are preferably chosen for their
desired characteristics such as capillary action, porosity,
etc. such products, which include a variety of foams, can be
25 provided with an anti-clotting or anti-coagulation coating.
Mat materials, such as polyurethane foam, may be suitable for
use with the suction sponge system 701.

The panel means 702 is affixed to the sponge outer face
710, and can comprise panel means such as the panel means 606

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26

described -above. The conduit means 706 can be substantially
similar to the conduit means 610 described above.

The suction sponge system 701 can be utilized i n a
variety of surgical and other medical procedures where fluid
5 evacuation, is desired. In particular, the suction sponge 701
combines the benefits of open-ended suction tubes and surgical
sponges by providing a system: for evacuating fluid from a
relatively wide area. •"

The panel means 702 and the sponge means 704 can be
10 modified in the operating room and matched to meet the
requirements of various: applications. For example, they can
be trimmed to accommodate the sizes and shapes of various
wounds and operating sites.

A suction tube 714 preferably has a proximate end 716
15 thereof located in close proximity to the outer sponge face
710 for enhancing the collection of fluid from the sponge
means 704. The suction tube proximate end 716 can be
positioned at various locations on the sponge outer face 710,
but a central location may be preferable to provide the
20 shortest average distances for fluid flow from the sponge
outer face 710 and the sponge perimeter edge 712.

X. Extremity Pluidi e Communication System floi

A f luidic connection system comprising a tenth modified

25 or alternative embodiment of the present invention is shown
in Figs. 20-23 and is. generally designated by the reference
numeral 801. The f luidic communication system 801 is designed
for application to an extremity (e.g., a penis) 802 and
generally comprises panel means 804, fluid control means 806

30 and conduit means 808.

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27

10

30

The panels means 804 can comprise, for example, any
suitable membrane or sheet-type material, such as those
discussed above, which can be affixed to the extremity by
placing a panel section 810 on each side thereof as shown,
with adhesive 812 on inner surfaces 814 of the panel sections
810 securing them together. Alternatively, the panel means
804 can be wrapped around an extremity and secured with other
fixation means, such as tape, sutures, etc.

The fluid control means 806 comprises a collar 820 of a
suitable sponge material (see the discussion above) with a
generally cylindrical configuration having proximate and
distal ends 822, 824 and a collar bore 826 extending
therebetween and open thereat. The collar 820 includes a slit
828 extending longitudinally between its ends 822, 824 for
15 providing access to the collar bore 826 whereby the collar 820
can be snapped in place over the conduit means 808.

The conduit means 808 comprises a multi-lumen catheter
tube 829 with a proximate end 830 having a collector balloon
831 for inflation within the bladder 833 of a patient and a
20 distal end 832. The catheter tube 829 includes an air lumen
834 in communication with the balloon 831 for inflating same,
a urine lumen 836 which extends generally axially from the
balloon 831, an irrigation lumen 833 which terminates at an
irrigation outlet 840 in spaced relation outwardly from the
proximate end 830, and a suction lumen 842 which terminates
at a suction port 840 which can be located in proximity to the
c liar distal end 824 in f luidic communicati n with the collar
820. The air, irrigation and suction lumens 834, 838 and 842
can be provided with suitable connectors 846, 848, 850
respectively, e.g., "Luer-Lock" type connectors for f luidic

25

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28

connection to suitable fluidic devices (e.g., pneumatic
squeeze bulbs, collection bags, pumps and suction sources)
which are commonly used for these purposes. The urine lumen
836 terminates at a bell-shaped female end 852 which can be
5 connected to a suitable collection bag via a tube.

A spiral groove 854 is formed in the catheter tube 829
and extends generally from the area of the irrigation outlet
840 to the suction port 844 and provides a passageway for
irrigating fluid which can be introduced through the
10 irrigation lumen 838 and evacuated through the suction lumen
842 and generally functions to irrigate and flush the urethra,
thereby reducing risks of infection and bacteriological
activity in the urethra.

The collar 820 is preferably installed with its proximate
15 end 822 against the meatus 856. Various configurations of the
conduit means 808 can be employed, for example, the irrigation
lumen 838 can be eliminated. The extremity fluidic connection
system 801 can be utilized to treat other extremities, such
as hands, arms, feet, legs, digits, etc. Suitable panel means
20 804, fluid control means 806 and conduit means 808 can be
selected for particular applications.

XX. Cinch Loop Pasteup sp

A cinch loop fastener 52 as shown in Figs. 6 and 9 is
shown in an intravenous tube system 901 in Figs. 24-30 as a
tenth modified or alternative embodiment of the present
inventi n. The IV tube system 901 includes panel means 902,
conduit means 904 comprising a sheath 906 and an intravenous
tube 908, and the cinch loop fastener 52. The discussions of
panel means and the conduit means above pertain to the panel

W ° 92/20299 PCT/US92/040.9

29

means 902 and the conduit means 904, which can assume various
configurations and comprise various materials within the scope
of the present invention.

The cinch loop fastener 52 includes a hub 910 with a
5 generally oval configuration and a slot 912 , a relatively wide
base leg 914 and a relatively narrow wrap leg 916. Adhesive
918 can be applied to a base leg outer surface 920 and covered
by a removable, protective adhesive cover 922. A loop or pile
portion 924 of the hook-and-loop fastener 54 (e.g., "Velcro"
10 fastener) can be applied to an inner surface 926 of the base
leg 920 and a hook portion 928 thereof can be applied to an
inner surface 930 of the wrap leg 916.

Figs. 27-30 show wrapping the IV tube 908 with the wrap
leg 916 and securing the cinch loop fastener 52 in its closed
15 configuration adhered to the panel means 902 over an IV site
932. These steps involve extending a distal end 934 of the
wrap leg 916 through the slot 912, returning the wrap leg 916
outwardly from under the hub 910, and folding the wrap leg 916
back over the base leg- 914 for attachment of the hook-and-loop
20 fastener 54. The wrap leg 916 thus pivots around the hub 910
through about one and one-half turns, or about 540 degrees.

The cinch loop fastener 52 can be used for securing a
variety of tube and sheaths on a variety of surfaces,
including panels, dressings and fasteners such as those
25 described herein.

It is. to be understood that while certain forms of the
present invention have been illustrated and described herein,
it is not to be limited to the specific forms or arrangement
or parts described and shown.

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PCI7US92/04019

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C L A T M «

What is claimed and desired to be secured by Letters Patent
is as follows:

1. A line fastening system, which, comprises:

(a) a membrane assembly including first and second
membrane panels each having: an adhesive face, said:
membrane assembly including a seam whereat said
panels are adhesively joined together at their
respective adhesive faces; and

(b) membrane-to-line fastening means for fastening the
membrane assembly to the line.

2. The invention of claim l, which, includes:

(a) a sheath assembly having a generally tubular
configuration, proximate and distal ends, and a
sheath passage- extending between said sheath ends,
said sheath assembly comprising a flexible
material;

(b) membrane-to-sheath fastening means for fastening
said membrane assembly to said sheath, assembly; and

(c) sheath-to-tube fastening means for fastening said
sheath assembly to said tube.

3. The invention of claim 2, which includes:

(a) said membrane-to-sheath fastening means comprising
said sheath assembly being adhesively secured
within said membrane assembly seam.

PCT/US92/04019

31

The invention of claim 3 wherein:

(a) said sheath assembly is secured in said membrane
assembly seam in proximity to said sheath assembly
proximate end; and

(b) said sheath assembly includes a split mouth at its
proximate end with a pair of tabs each connected to
a respective membrane assembly panel.

5. The invention of claim l, which includes:

(a) said first membrane panel including first and
second end edges and a pair of opposite side edges;

(b) said first membrane panel further including a first
flap panel extending from the first end edge
thereof;

(c) said second membrane panel comprising a second flap
panel adhesively secured to said first flap panel
at the seam; and

(d) said first and second flap panels forming a
membrane assembly extension.

6. The invention of claim 2, which includes:

(a) an adhesive layer on said sheath assembly within
said sheath passage.

7. The invention of claim 6, which includes:

(a) a sheath adhesive backing strip extending through
said sheath passage in releasable engagement with
said sheath adhesive layer.

The invention of claim l wherein:

WO 92/20299

PCI7US92/04019

32

said sheath-to-line fastening means comprises
cinch belt with a hook-and-loop fastener.

a

9.

The

invention of claim l wherein:

(a)

said sheath-to-line fastening means comprises
twist tie.

a

10. The inventioa of claim l wherein:

(a) said sheath-to-line fastening means comprises a
hook-and-loop fastener mounted on said sheath, with
hook and loop portions thereof positioned in spaced

. A system for fastening a nasogastric tube to a patient's
face, which comprises:

(a) a membrane- assembly including a first panel having
first and second end edges, opposite side edges, a
first flap panel extending from said first end edge
and an adhesive layer;

(b) a second body panel comprising a second flap panel
having an adhesive layer and secured to the first
flap panel at a membrane assembly seam formed by
said body panel adhesive layers; and

(c) sheath-to-tube fastening means for fastening said
sheath assembly to said nasogastric tube.

relation on. said sheath.

33

• The invention of claim 11, which includes:

(a) a sheath assembly having a generally tubular
configuration with proximate and distal ends and a
sheath passage extending between said sheath
assembly ends; and

(b) membrane-to-sheath fastening means for fastening
said membrane assembly to said sheath assembly and
comprising said sheath assembly being secured in
proximity to its proximate end between said panels
at said membrane assembly seam.

The invention of claim 11, which includes:
(a) each said flap panel having a proximate edge
adjacent to said first panel first end edge and a
distal edge, one of said flap panels terminating at
a distal edge positioned in spaced relation beyond
the distal edge of said other flap panel; and

(b) an adhesive backing on said one flap panel between
the flap panel distal edges.

• A system for fastening a surgical sponge to a suction
tube, which comprises:

(a) a membrane assembly including first and second body
panels each having an adhesive face, first and
second end edges and opposite side edges;

(b) said membrane assembly including a membrane
assembly seam whereat said first and second body
panels are, adhesively connected adjacent to their
respective first ends;

(c) said body panels- comprising a flexible material;

(d) a sheath, assembly having a generally tubular
configuration with proximate and distal ends and a
sheath passage extending therebetween, said sheath
assembly having: ct split, open mouth at its.
proximate end with first and second sheath mouth
tabs;

(e) sponge fastening means, for fastening said spong
between said body panels with a portion thereof
between said sheath mouth tabs; and

(f) sheath-to-tube fastening means for fastening the
sheath to a suction tube.

The invention of claim 14 wherein:

(a) said surgical sponge includes a backing layer with
less permeability than a remaining portion of said
sponge.

. A system for fastening an intravenous tube, a needle and
a cannula to a patient, which includes:
(a) a membrane assembly having a pair of body panels
each having first and second ends and opposite side
edges ;

. (b) said membrane assembly including a membrane
assembly seam extending transversely thereacross
whereat said membrane panels are adhesively joined
together at their respective adhesive faces in
proximity to their respective first ends;

(c) each said body panel comprising a semi-permeable
material with an adhesive layer;

(d) a sheath assembly with a generally tubular
configuration-, proximate and distal ends and a
sheath passage extending therebetween;

(e) patient attachment means for securing one of said
body panels to a patient in covering relation over
said cannula; and

(f) sheath-to-tube fastening means for fastening said
sheath to said tube with said tube fluidically
communicating with said needle.

The system according to claim 16 wherein:

(a) said needle extends through said one body panel to
said cannula; and

(b) said tube is fastened on the outside of said
sheath.

36

18. The invention of claim 16 wherein:

(a) said tube is positioned at least partly within said
sheath passage.

19. A system for fastening a Foley catheter including a
drain tube to a patient's penis, which includes:

(a) a membrane assembly having first and second body
panels each having an adhesive face;

(b) said membrane assembly including a membrane seam
whereat said panels are adhesively joined together
at their adhesive faces;

(c) fastening; means- for fastening said membrane
assembly to the patient's penis; and

(d) membrane-to-tube fastening means, for fastening said
membrane to said tube.

20. The invention of claim 19 which includes:

(a) a sheath assembly having a generally tubular
configuration, proximate and distal ends and a
sheath passage extending between said ends;

(b) said sheath assembly extending through said
membrane assembly seam between said membrane
assembly panels and being adhesively secured
thereto in proximity to said sheath assembly
proximate end; and

(c) sheath-to-tube fastening means for fastening said
tube to said sheath with said tube extending
through said sheath passage.

37

21. The invention of claim 19 wherein:

(a) said means for fastening said membrane assembly to
the patient's penis comprises said adhesive on
first body panel;. and

(b) said membrane assembly at least partly encircles
said tube and is fastened thereto.

22.

A system for fastening a pair of tubes to a patient,
which comprises:

(a) a membrane assembly including first and second
panels each having an adhesive face, first and
second end edges and opposite side edges;

(b) said membrane assembly including a membrane
assembly seam whereat said panels are adhesively
joined together at their adhesive faces adjacent to
their first end edges;

(c) a sheath assembly having a generally tubular
configuration, proximate and distal ends and a
sheath passage extending between said sheath ends,
said sheath assembly comprising a flexible
material;

(d) said sheath assembly being secured to said membrane
assembly within said membrane assembly seam in
proximity to said sheath assembly proximate end;
and

(e) first and second sheath-to-tube fastening means
each adapted for fastening a respective tube to
said sheath assembly.

38

The invention of claim 22 which includes:

(a) said sheath assembly being split adjacent to its
distal end and including first and second sheath
half sections; and

(b) each said tube being fastened to a respective
sheath half section.

The invention of claim 22 wherein:

(a) said sheath assembly includes first and second
branches each fastened to a respective tube.

The invention of claim- 24 wherein:

(a) said sheath assembly first, and second branches are
interconnected by a T-connector.

The invention of claim 24 wherein:

(a) said sheath assembly first and second branches are
interconnected by a Y-connector.

39

27. The invention of claim 22, which includes:

(a) a second sheath assembly having a generally tubular
configuration, proximate and distal ends and a
sheath passage extending between said sheath ends,
said second sheath assembly comprising a flexible
material;

(b) said second sheath material being secured to said
membrane assembly within said membrane assembly
seam in proximity to said second sheath assembly
proximate end; and

(c) said second tube being fastened to said second
sheath assembly.

8. A method of fastening a flexible line to a patient,
which comprises the steps of:

(a) providing a membrane assembly including first and
second membrane panels each having first and second
end edges, opposite side edges and an adhesive
face;

(b) adhesively joining respective portions of said
membrane panel adhesive faces adjacent to said
panel first end edges to form a seam thereat;

(c) providing a sheath with a generally tubular
configuration and proximate and distal ends with a
sheath passage extending therebetween;

(d) adhesively securing the sheath within the membrane
assembly seam;

(e) fastening said membrane panels at their adhesive
faces to the patient; and

(f) fastening the tube to the sheath.

WQ92/2U299 PC1/USV2/04019

40

29. The invention of claim 28 wherein said tube comprises a
nasogastric tube and which includes the additional steps
of:

(a) releasing said tube from said sheath;

(b) repositioning said tube^with respect to said
patient; and

(c) reattaching said sheath to said tube.

30. The invention of claim 28 wherein said tube comprises an
intravenous tube, and which includes the additional
steps* of:

(a) inserting a cannula into the patient at a puncture
site;

(b) providing a heparin lock on said cannula;

(c) covering said puncture site and said cannula with
said membrane assembly;

(d) inserting a hypodermic needle through said membrane
assembly and into said heparin lock; and

(e) connecting said hypodermic needle to- said
intravenous tube.

The invention of claim 28 wherein said tube comprises
part of a Foley catheter, and which includes the
additional steps of:

(a.) inserting the- Foley catheter into the urethra of a
patient;

(b) placing the membrane assembly over the
urethra/catheter junction; and

(c) inserting the catheter tube through the sheath.

The invention of claim 30 wherein a second tube is
connected to the patient, and which includes the
additional steps of:

(a) providing a second sheath assembly;

(b) connecting said second sheath assembly to said
membrane assembly; and

(c) connecting said second tube to said second sheath
assembly .

f<-l/Uiiy2/U40l9

42

A method of fastening a nasogastric tube to a patient
which includes the steps of:

(a) providing a membrane assembly with a first body
panel including first and second end edges,
opposite side edges, an extension flap extending
from said first end edge and an adhesive face;

(b) placing a second flap panel with an adhesive layer
..against the: adhesive, layer -of said body panel;

(c) providing an exposed adhesive area on said
extension flap with said second flap panel between
said exposed adhesive area and said body panel
first end edge;

(d) adhesively attaching the body panel to the
patient's f ace- over the. patient's nose with the
second flap panel in proximity to the patient's
nostrils; and

(e) adhesively attaching said exposed adhesive area of
said extension flap to said nasogastric tube.

43

34

A method of fastening a surgical sponge with first and
second faces to a suction tube, which comprises the
steps of:

(a) providing a membrane assembly with first and second
membrane panels each haying first and second end
edges, opposite side edges: and an adhesive face;

(b) adhesively attaching said membrane panels together
at their adhesive faces adjacent to their first end
edges to form a membrane assembly seam;

(c) providing a sheath assembly with a generally
tubular configuration, proximate distal ends and a
passage extending therebetween;

(d) fastening said sheath assembly within said membrane
assembly seam in proximity to said sheath assembly
proximate end;

(e) placing a portion of said sponge between said
membrane assembly panels; and

(f) adhesively securing said membrane assembly panels
to said sponge with said sponge fluidically
communicating with said sheath.

35. The invention of claim 34 , which includes the additional
step of:

(a) providing said surgical sponge with a layer having
less permeability than a remainder of said surgical
sponge.

wusu/aizyy PCT/US92/U40I9

44

36. a wound dressing, which includes:

(a) wound covering means with an inner contact surface
and an outer surface;

(b) fixation means for releasably affixing said
covering means on the wound;

(c) said covering means: having an interior portion with
an opening extending between- and open at said inner
and outer surf acesr thereof:;. -

(d) conduit means having a proximate end f luidically
communicating with said wound and a distal end
located outwardly front saitf outer surface; and

(e) fluid control means disposed intermediate said
covering means, and said wound for controlling a
flow of fluid from said wound to said conduit means
proximate end..

37. The invention of claim: 36 wherein t

(a) said fluid control means includes an edge; and

(b) said wound covering means is positioned over said
fluid control means, edge with said tube means
extending under said fluid control means edge.

45

38. The invention of claim 36 wherein:

(a) said fluid control means includes an interior
portion with an opening; and

(b) said wound covering means is positioned over said
fluid control means interior portion with said tube
means extending through said fluid control means
opening.

39. The invention of claim 36 wherein:

(a) said wound covering means is substantially larger
in area than said fluid control means and covers
same.

40. The invention of claim* 36 wherein:

(a) said fluid control means is substantially larger in
area than said wound covering means.

41. The invention of claim 36 wherein:

(a) said fluid control means comprises a gel material.

4Z. The invention of claim 36 wherein:

(a) said fixation means comprises a pressure
differential across said wound dressing.

43. The invention of claim 36 wherein:

(a) said fluid control means comprises a mat material.

44. The invention of claim 36 wherein:

(a) said fluid control means comprises a sponge
material.

46

45. The invention of claim 36 wherein:

(a) said fluid control means comprises a foam material.

46. A system for fluidically connecting a vacuum source with
a wound site, which comprises:

(a) panel means with an inner surface, an outer surface
and an interior portion having an opening extending*
between said inner and outer surfaces;

(b) fixation means for mounting said panel means in
covering relation over said wound site;

(c) sheath means having a generally tubular
configuration with a proximate end positioned in
proximity to said opening and a distal end
positioned outwardly from said opening, said sheath
means extending through said opening, said sheath
means including a passage extending between said
sheath proximate and distal ends;

(d) a suction tube including a proximate end positioned
under said panel means and a distal end connected
to the suction source externally of the panel
means, said suction tube extending through the
sheath passage;

. (e) sheath-to-tube clamping means for clamping said
sheath on said tube in fluid-tight engagement; and
(f) fluid control means positioned intermediate said
wound site and said panel means for controlling
fluid flow from said wound site to said suction
tube.

The invention of claim 4 6 wherein:

(a) said fixation means comprises a pressure
differential across the panel means caused by the
vacuum source.

The invention of claim 46 wherein:

(a) said fixation means includes adhesive means for
mounting the panel to skin adjacent the wound site.

1 * ' «-J74/y^ U|7

4 8

A suction-assisted surgical sponge system, which
includes:

(a) panel means including a pair of panel sections each
having inner and outer surfaces, said panel means

- including a seam whereat said panel sections are
joined together;

(b) sponge means having an- inner surface , an outer
surface and a perimeter edge;

(c) fixation means for fixing said panel section inner
surfaces to said sponge means outer surface;

(d) conduit means including a sheath having a proximate
end mounted in said panel means seam and
terminating in proximity to said panel section
inner surfaces., a sheath distal end located
outwardly from said panel section outer surfaces
and a sheath passage extending through said sheath
between the ends thereof;

(e) a suction tube including a proximate end in f luidic
communication with said sheath passage and a distal
end adapted for connection to a suction source; and

(f) means for connecting said suction tube to said
sheath with at least a portion of said suction tube
in said sheath passage in a relatively fluid-tight
engagement.

49

50.

An extremity fluidic communication system, which
comprises :

(a) panel means including inner and outer surfaces;

(b) fixation means for affixing said panel means to
said extremity;

(c) conduit means including a proximate end f luidically
communicating with the extremity, a distal end
positioned outwardly from the panel means and a
conduit passage extending between the conduit means
ends; and

(d) fluid control means for controlling fluid flow from
said extremity to said conduit.

51. The invention of claim 50 wherein:

(a) said fluid control means comprises a sponge
material collar with proximate and distal ends and
a passage extending between said ends, said passage
receiving said conduit means.

52. The invention of claim 51 wherein:

(a) said collar includes a slit extending
longitudinally between said collar ends and
radially to said collar passage for passing said
conduit means therethrough into said passage.

50

53. The invention of claim 50 wherein:

(a) said conduit means comprises a Foley catheter with
a urine lumen, an air lumen and a suction lumen,
said suction lumen terminating at a suction port in
< fluidic communication with said fluid control

means .

54. The invention of claim S3 wherein:

(a) said conduit means includes an irrigation lumen
extending from said conduit means distal end to an
irrigation outlet in spaced relation from said
conduit means proximate end; and

(b) said conduit means . includes a spiral irrigation
groove extending along said conduit means from said
irrigation outlet to said fluid control means.

5. A cinch loop fastener, which comprises:

(a) a hub including a slot;

(b) a base leg extending from said hub in a first
direction;

(c) a wrap leg extending from said hub in a second
direction;

(d) means- for wrapping said wrap leg around an object
to be fastened and extending same through said
slot; and

(e) means for fastening said wrap leg on said base leg.

. The invention of claim 55 wherein:

(a) said means for fastening said wrap leg on said base
leg comprises a hook-and-loop fastener.

51

The invention of claim 55 wherein:

(a) said base leg includes an outer surface mounting a
portion of said means for fastening said wrap leg
to said base leg and an inner surface; and

(b) said base leg includes a layer of adhesive on said
inner surface thereof.

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